Associate Quality Systems Audits and Inspections

7555-Janssen Pharmaceutica NV Legal Entity; Geel; Sur place; EUR 55 000 - 75 000; Plein temps

Avantages offerts par ce poste

Team environment

Growth opportunities

Inclusive workplace

Competitive compensation

Impact on patient outcomes

Résumé du poste

Johnson & Johnson is seeking a detail-oriented Associate, CSQ Quality Systems – Audits & Inspections to join the Clinical Supply Quality team. You will support planning, coordination, and execution of internal and external audits across Beerse, Leiden, and ECSQ, ensuring timely scheduling and CAPA follow-up.

The role requires strong GxP knowledge, audit management, and cross-site collaboration, with Dutch and English proficiency as essential assets.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or related field; advanced degree preferred.
• Minimum 2–4 years in quality assurance, quality systems, or audits within a regulated environment.
• Strong knowledge of GxP regulations, ICH guidelines, and health authority inspection expectations.
• Experience with audit planning, execution, and inspection readiness; auditor certification a plus.
• Experience with electronic quality systems and data reporting tools (Power BI, Tableau).
• Dutch and English proficiency is a must; additional European languages are an asset.

Responsabilités

• Audit Planning & Coordination: support annual internal and external audit plans across CSQ.
• Internal Audits: support execution of internal audits and CAPA tracking.
• External Audits: coordinate external audits of suppliers and service providers.
• Inspection Readiness: assist in preparing for health authority inspections across sites.
• Inspection Support: provide logistical and documentation support during inspections.
• CAPA & Follow-up: monitor findings and ensure timely responses and corrective actions.
• Metrics & Reporting: track KPIs and provide CSQ leadership with insights.
• Documentation & Compliance: maintain audit-ready records per GxP and ALCOA+ standards.

Connaissances

GxP knowledge

Auditing

Cross-site coordination

Analytical skills

Communication skills

Formation

Bachelor's degree in Life Sciences

Advanced degree preferred

Outils

COMET

Veeva

TruVault

SUMMIT

Power BI

Tableau

Description du poste

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

Job Function: Non-Standard Job Sub Function: Workday Associate 01 Job Category: Non-Standard All Job Posting Locations: Beerse, Antwerp, Belgium

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine

About the Role

We are seeking a detail-oriented Associate, CSQ Quality Systems – Audits & Inspections to join our Clinical Supply Quality (CSQ) team. This role is supporting the Sr Associate in planning and coordination of internal and external audits and for the preparation of inspections by health authorities across CSQ, including Beerse (DPDS), Leiden (ex-Vaccines), and External Clinical Supply Quality (ECSQ). The ideal candidate brings solid expertise in GxP quality systems, audit management, and inspection readiness, with a strong focus on planning, documentation, and cross-site coordination.

Key Responsibilities

• Audit Planning & Coordination: Support in the maintenance, scheduling and execution of the annual internal and external audit plan across CSQ (Beerse DPDS, Leiden ex-Vaccines, and ECSQ), ensuring identified lead and support auditors, and timely scheduling as per approved audit plan(s).
• Internal Audits: Support the execution of internal (self-inspection) audits, tracking scope, timelines, findings, and completion of corrective and preventive actions (CAPAs).
• External Audits: Support the coordination of external audits of suppliers, contract manufacturers, and service providers, aligning stakeholders and consolidating outcomes.
• Inspection Readiness: Support Sr Associate in the preparation for inspections by health authorities, ensuring sites and teams are inspection-ready through gap assessments, mock inspections, and documentation reviews.
• Inspection Support: Provide logistical and documentation support during health authority inspections, including management of front-room/back-room activities and request tracking.
• CAPA & Follow-up: Monitor audit and inspection findings to closure, ensuring responses and CAPAs are robust, timely, and inspection-defensible.
• Metrics & Reporting: Track and report key audit and inspection metrics (KPIs), providing actionable insights and status updates to CSQ leadership.
• Documentation & Compliance: Maintain accurate, complete, and audit-ready records in alignment with GxP requirements, ALCOA+ principles, and J&J global standards.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or a related field; advanced degree preferred.
• Minimum 2 – 4 years of experience in quality assurance, quality systems, or audits and inspections within a regulated environment (e.g., pharma, biotech).
• Strong knowledge of GxP regulations, ICH guidelines, and health authority inspection expectations (e.g., FDA, EMA).
• Demonstrated experience in audit planning, execution, and inspection readiness; auditor certification is a plus.
• Experience with electronic quality systems (e.g., COMET, Veeva, TruVault, SUMMIT or similar) and data reporting tools (e.g., Power BI, Quickbase, Tableau).
• Excellent organizational, analytical, and communication skills, with the ability to manage multiple priorities across sites.
• Dutch and English proficiency is a must; additional European languages are an asset.

What We Offer

• A collaborative and mission-driven team environment
• Opportunities for professional growth and career development
• A dynamic and inclusive workplace environment
• Competitive compensation and benefits package
• The chance to make a meaningful impact on clinical supply quality and patient outcomes.

At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time.

The anticipated base pay range for this position is: €0,00 - €0,00

Benefits: In addition to base pay, we offer the following benefits:

• an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year
• vacation days
• parental leave for a minimum of 12 weeks
• bereavement leave
• caregiver leave
• volunteer leave
• well-being reimbursement
• programs for financial, physical and mental health
• service anniversary and recognition awards
• subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.